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Phase II Study to Assess Safety, Pharmacokinetics and Efficacy of SL-1002 for Limb Spasticity (RAISE Trial)
Phase 2
Waitlist Available
Research Sponsored by Saol Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of study drug administration to end of study visit (day 168)
Summary
This trial is testing a new treatment called SL-1002 to help people with muscle stiffness in their arms or legs. The study will include 32 patients who will receive the treatment. Researchers want to see if SL-1002 can safely reduce muscle stiffness and improve flexibility.
Eligible Conditions
- Spasticity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of study drug administration to end of study visit (day 168)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of study drug administration to end of study visit (day 168)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of treatment emergent adverse events (TEAEs) overall
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SL-1002Experimental Treatment1 Intervention
SL-1002 injectable solution, single dose
Group II: Matching placeboPlacebo Group1 Intervention
Matching placebo injectable solution, single dose
Find a Location
Who is running the clinical trial?
Saol Therapeutics IncLead Sponsor
2 Previous Clinical Trials
166 Total Patients Enrolled